FDA Approves Regeneron’s Eylea for Infants With ROP

Title: Regeneron’s Eylea Receives FDA Approval for Infants With ROP


Exciting news in pediatric ophthalmology: The US Food and Drug Administration (FDA) has recently granted approval for Regeneron Pharmaceuticals’ Eylea to treat infants with retinopathy of prematurity (ROP). This FDA approval marks a significant advancement in the management of ROP, a potentially blinding disorder affecting premature infants’ retinas. In this blog post, we will focus on the key points surrounding the FDA approval of Regeneron’s Eylea for infants with ROP and its impact on the healthcare community and affected families.

Key Points

  1. Retinopathy of Prematurity: A Significant Concern for Premature Infants: ROP is a complex eye disorder that primarily affects premature infants, born before 31 weeks of gestation or with a birth weight less than 1500 grams. ROP occurs when abnormal blood vessels develop in the retina, leading to scarring, retinal detachment, and potential vision loss if left untreated. It is a major cause of childhood blindness globally, making early detection and effective treatment crucial.
  2. Eylea: A Breakthrough Treatment for ROP: Eylea (aflibercept) is a well-established medication already approved for various retinal disorders in adults. This FDA approval is momentous as it now extends Eylea’s use to infants with ROP. Eylea works by inhibiting the growth of abnormal blood vessels in the retina and reducing the risk of complications that can lead to irreversible vision loss.
  3. Efficiency and Safety Considerations: The FDA’s approval of Eylea for infants with ROP was based on robust clinical trial data demonstrating its efficacy and safety in this patient population. The trials showed that Eylea significantly reduced the need for invasive procedures, such as laser therapy or surgery, to treat ROP. The medication’s efficacy and safety profile have been recognized, offering reassurance to healthcare providers and affected families.
  4. Early Intervention and Improved Outcomes: ROP requires early detection and intervention to prevent progressive vision loss or blindness. The FDA approval of Eylea provides healthcare providers with an additional treatment option to address the needs of infants with ROP, potentially improving visual outcomes and reducing the burden of more invasive treatments. Early intervention with Eylea may offer infants a better chance at preserving their vision and achieving optimal eye health.
  5. Collaboration and Continued Research: The FDA’s approval of Eylea for infants with ROP is a result of collaboration between Regeneron Pharmaceuticals and the ophthalmology community. This achievement highlights the importance of ongoing research and collaboration in advancing treatment options for rare and complex pediatric conditions. It also underscores the commitment of pharmaceutical companies and healthcare professionals to improving the lives of vulnerable infants and their families.
  6. Enhanced Access to Eylea: With FDA approval, Eylea will now be more accessible to infants with ROP, providing an important additional treatment option to healthcare providers. Improved access to this breakthrough medication is vital in addressing the urgent medical needs of premature infants at risk of developing ROP and preventing long-term visual impairments.
  7. Educating and Supporting Families: The approval of Eylea for infants with ROP brings new hope to families facing the challenges of this potentially blinding condition. It is essential that healthcare providers, advocacy groups, and pharmaceutical companies collaborate to ensure families receive appropriate education and support. Empowering families with knowledge about available treatments can facilitate informed decision-making and contribute to better outcomes and quality of life for infants living with ROP.


The FDA approval of Regeneron Pharmaceuticals’ Eylea for infants with retinopathy of prematurity marks a significant milestone in the field of pediatric ophthalmology. This approval provides an additional treatment option to healthcare providers, potentially improving visual outcomes and reducing the need for more invasive interventions. Collaboration between pharmaceutical companies, healthcare professionals, and advocacy groups is crucial in advancing research and ensuring access to life-changing treatments for vulnerable infants. The approval of Eylea underscores the commitment to addressing unmet medical needs and highlights the potential for ongoing advancements in pediatric healthcare. It ushers in new hope for families affected by ROP, bringing us closer to achieving the goal of preventing childhood blindness and optimizing the eye health of premature infants.